CN105561416B - System for extracorporeal blood treatment - Google Patents
System for extracorporeal blood treatment Download PDFInfo
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- CN105561416B CN105561416B CN201510646690.2A CN201510646690A CN105561416B CN 105561416 B CN105561416 B CN 105561416B CN 201510646690 A CN201510646690 A CN 201510646690A CN 105561416 B CN105561416 B CN 105561416B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1601—Control or regulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3672—Means preventing coagulation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3672—Means preventing coagulation
- A61M1/3675—Deactivation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1654—Dialysates therefor
- A61M1/1656—Apparatus for preparing dialysates
Abstract
A system for extracorporeal blood treatment, having: a blood filtration device; a member for pumping blood through the blood filtration device; a citrate adding member, arranged upstream of the blood filtration device, configured to add citrate to the blood; a calcium addition member, disposed downstream of the hemofiltration device, configured to add a calcium solution to the blood; and a control member configured to activate or deactivate the citrate adding member and/or the calcium adding member, wherein the control member activates the citrate adding member at the start of the blood treatment and filters the blood with the activated citrate adding member for a first period of time and continues to operate the citrate adding member until the end of the blood treatment; at this point in time, the citrate adding means is deactivated, the control means activates the calcium adding means after a first period of time has elapsed, the control means continues to operate the calcium adding means in an active state during the blood treatment to stably maintain the user-determined rate of calcium addition when the total external blood volume in the system has been filtered and citrate treated, and after the blood treatment is ended, the calcium adding means in an active state continues to operate until a second period of time has elapsed after the treatment is ended.
Description
Technical Field
The present invention relates to a system and method for flexible citrate anticoagulation during extracorporeal blood treatment using feed forward control.
Background
During extracorporeal blood treatment (e.g. hemodialysis), anticoagulation is necessary to prevent thrombus formation and clotting of the system in the hemodialysis machine, in particular clotting of the blood, the filters, tubing and/or the dialyzer of the system. One possible anticoagulation method is citrate-calcium anticoagulation. This method is particularly useful where systemic heparin anticoagulation is contraindicated. During citrate-calcium anticoagulation, citrate is added to the blood in the arterial branch, which means before/upstream the dialyzer of the system for extracorporeal blood treatment (e.g. hemodialysis machine). The added citrate prevents coagulation of the blood by binding ionized calcium present in the extracorporeal blood flow within the tube/filter of the extracorporeal blood treatment machine. As the citrate-treated blood reaches the hemodialysis machine (filter), citrate and calcium bound thereto are removed from the extracorporeal blood flow. To ensure adequate calcium homeostasis in the treated patient, it is necessary to replenish the removed calcium into the extracorporeal blood flow before the treated blood is returned to the patient. Thus, the calcium solution is added to the blood in the venous branch, which means after/downstream of the dialyzer of the hemodialysis machine. Both the amount of citrate necessary to achieve an anticoagulation effect and the amount of calcium necessary for replacement should be defined by the physician or skilled user responsible for blood handling (e.g., based on hospital protocols and the specific requirements of the individual patient).
State of the art
Several methods of citrate anticoagulation dialysis are known from the state of the art. For example, WO2010/148194 discloses an anticoagulation strategy in which calcium is replaced by means of a dialysate instead of a calcium solution added to the venous branch of a hemodialysis machine. However, it is difficult to directly control the rate of calcium addition with such a system. Therefore, in case the calcium solution is added directly into the venous branch of the hemodialysis machine, the calcium addition rate is preferred, since in this case the calcium addition rate can directly undergo immediate manipulation and is not affected by e.g. diffusion of ions through the dialysis fluid.
Furthermore, several systems and methods for controlling blood calcium levels during extracorporeal blood treatment are known from the state of the art. These conventional systems and methods use a classical feedback control loop that employs various sensors to monitor the current blood calcium level and adjust citrate and calcium addition rates accordingly. The main drawbacks associated with this approach are: first, due to the complexity of human calcium metabolism, even advanced-and therefore expensive-sensors capture the true calcium concentration in the patient's blood (free ionized calcium and protein-bound calcium, etc.) relatively inaccurately; secondly, such automatic feedback mechanisms hardly provide any flexibility to the user (e.g. a doctor) to modify the settings of the hemodialysis machine for each patient's specific and individual requirements, even during treatment.
For example, WO2007/038347 discloses a system for automatically controlling the electrolyte level of a patient during hemodialysis by means of an electrolyte sensor, a fluid loss sensor and a sensor measuring the blood flow through a hemofilter. The information obtained by these sensors is used to control the rate of addition of citrate and calcium solutions to the patient's blood. Such systems are rather complex and expensive to manufacture due to the necessity of using multiple sensors, and require sophisticated control algorithms to ensure the correct integration of several streams of information from several sensors. This makes the overall system less user friendly in use and increases the susceptibility of the system to user error.
Similarly, another device for citrate anticoagulation is known from WO 2009/026603, which uses a calcium sensor to monitor blood calcium levels and uses feedback control to adjust citrate and calcium solution addition rates in order to maintain blood calcium levels at a certain predetermined calcium concentration.
The system of WO2007/101064a1 aims at controlling the electrolyte balance in the blood of a patient by means of a Raman spectrometer. These spectrometers further add to the manufacturing cost of the hemodialysis system.
The method of US2012/0203159a1 is similarly intended to maintain a specific calcium concentration in the blood of a patient by a feedback mechanism involving a sensor. In addition, a specific formula is given to calculate the possible setting range of the calcium value.
In all the devices known according to the state of the art described above, elaborate equipment in the form of sensors and complex calculation and control algorithms are required for a fully automatic control of the calcium level in the blood of a patient, wherein the blood calcium level is stably maintained within a predetermined range. This structural complexity increases the manufacturing costs of such devices and makes these devices less user friendly in operation.
Furthermore, such conventional methods for citrate-coagulation allow little or no flexibility in adjusting the calcium dose during blood processing. In addition to this, human calcium metabolism is a very complex system. Almost every body cell contains calcium and these ions have high mobility. Further complications are added in this case because calcium in the blood can exist in free ionized form as well as in protein bound form. Of these two substances, only free ionized calcium is responsible for coagulation. However, upon removal of free ionized calcium from the blood stream, calcium ions bound to the protein are also released from the protein. This inherent complexity makes it very difficult to control calcium metabolism during extracorporeal blood treatment using an external source (e.g. a sensor). Increased flexibility in treatment parameters is needed, particularly as personalized medicine increases, allowing physicians to continually adjust treatment parameters (e.g., calcium concentration in blood) based on their experience (knowledge that can be practiced during the treatment process). This allows the physician to tailor treatment parameters to the specific requirements of an individual patient and to flexibly respond to emergency situations during treatment.
Disclosure of Invention
It is an object of the present invention to provide a system for extracorporeal blood treatment and a method of controlling such a system for extracorporeal blood treatment which provide increased flexibility in setting parameters during blood treatment while ensuring that the correct amount of calcium is replaced in the patient's blood (i.e. only as much as calcium has been removed during filtration), thereby reducing the manufacturing costs of the system for extracorporeal blood treatment and facilitating the operation of the system for extracorporeal blood treatment.
The gist of the present invention is to use some feed forward control mechanism to determine the time periods for citrate addition and calcium addition to the blood of a patient, respectively. At the beginning of the extracorporeal blood treatment, citrate is added to the blood. This is followed by a first period of time until citrate is added and the total extracorporeal blood volume is filtered. This first period of time thus corresponds to the time it takes for the system to run blood through the entire extracorporeal circuit for extracorporeal blood treatment once. After the total external blood volume has been cleared (i.e., the first time period has elapsed), calcium addition is started at a user-defined rate while citrate is still being administered, and the actual blood treatment (e.g., dialysis) is in operation. During the treatment period, which may be run for a given time, the user/physician may flexibly adjust the rate of calcium and citrate addition based on her or his experience and knowledge. At the end of the actual blood treatment, the addition of citrate is stopped (anticoagulation is no longer needed), but the addition of calcium is continued for a second period of time. This second time period corresponds to the time it takes for the system to run the blood through the whole extracorporeal circuit for extracorporeal blood treatment. Thus, if the blood flow rate has not been changed during the treatment process, the second time period is equal to the first time period. Based on the information about the volume of the extracorporeal circuit and the flow rate of blood through the hemodialyzer, the length of the second time period may be determined. The setting of the lengths of the first and second time periods in which only citrate addition or only calcium addition occurs provides a timing control mechanism that eliminates the need for complex sensors for directly monitoring and setting the calcium concentration. Furthermore, since the calcium supplementation during the second time period ensures that the amount of calcium removed from the blood during the treatment period is replaced, the physician can flexibly adjust the treatment parameters during the actual blood treatment. Briefly, according to fig. 2, extracorporeal blood is initially treated with citrate and this (continuously) citrate-treated blood is filtered through a semi-permeable membrane for a first period of time (calcium addition is still stopped). Subsequently (beginning a periodic treatment period), blood treatment (e.g., dialysis) performed at a user-defined setting (which can be adjusted during treatment) takes some time. At the same time, the citrate-bound calcium ions are filtered from the blood through a semi-permeable membrane (hemofilter or dialyzer), said ions being (continuously) replaced by calcium additions which have started at the end of the first time period. After treatment (at the end of the periodic filtration treatment period), calcium addition is continued for a second period of time (where citrate addition has stopped at the end of the periodic filtration treatment period) to replenish the blood calcium level in the treated blood before it is returned to the patient's body. Both the first and second time periods are the time periods required for the system to run blood through the entire extracorporeal circuit once. This time period corresponds to the extracorporeal volume of the system and the flow rate of the blood.
The system for extracorporeal blood treatment according to the present invention comprises: a blood filtration device; a member (e.g., a blood pump) for pumping blood through the blood filtration device; a citrate adding member (e.g. a citrate pump or an infusion line) arranged in the direction of blood flow, upstream of the blood filtration device/on an arterial branch of the system for extracorporeal blood treatment, and configured to add citrate to the blood; a calcium adding member (e.g. a calcium pump or an infusion line) arranged in the direction of blood flow, downstream of the hemofiltration device/on a venous branch of the system for extracorporeal blood treatment and configured to add a calcium solution to the blood; and a control means (e.g. an electronic control unit, ECU) configured to activate or deactivate (i.e. turn on and off) the citrate adding means and/or the calcium adding means and to define the rate of addition of the citrate adding means and/or the calcium adding means according to a user-defined setting. When the patient is connected to the system for extracorporeal blood treatment, the control means activates (i.e. opens) the citrate adding means at the start of the blood treatment. Subsequently, the citrate treated blood is filtered through the dialyzer for a first period of time while the citrate addition member remains active, prior to activating the calcium addition member. This first period of time corresponds to the time required for the system to run blood through the extracorporeal circuit for extracorporeal blood treatment once. This ensures that most of the ionized calcium is removed from the blood in the extracorporeal circuit while the blood treatment is performed, so that no blood clotting will occur. The control means maintains the citrate adding means in an active state when the blood treatment is started and continued, and additionally activates the calcium adding means after a first time period has elapsed. During blood processing, a user (such as a physician) may flexibly adjust the rate of calcium and citrate addition to maintain a user-determined calcium concentration in the patient's blood. The rate of calcium and/or citrate addition can be repeatedly varied by the physician during blood processing. After the blood treatment is finished (i.e. after the end of the last cycle of blood treatment), the control means deactivates (i.e. closes) the citrate adding means. However, after the blood treatment is ended, the control means continues to operate the calcium adding means in an active state (i.e. open) until a second period of time has elapsed after the end of the treatment. This second time period corresponds to the time it takes for the system to run blood through the entire extracorporeal circuit for extracorporeal blood treatment once. Thus, operating the calcium adding member in an active state during the second period of time ensures that virtually all the calcium extracted from the blood during the treatment period is replaced until the end of the second period of time.
By using a feed-forward mechanism to set the length of the second time period based on the length of the first time period, the need for a sophisticated sensor to detect the calcium concentration of blood is eliminated and the manufacturing costs of the system for extracorporeal blood treatment can be reduced. Furthermore, control of calcium dose and calcium concentration in blood during blood treatment is well within the hands of the physician, as the timing coordination of simultaneous blood treatment and simultaneous calcium supplementation with citrate addition and post-blood treatment calcium supplementation ensures adequate calcium supplementation to the patient's blood, independent of the treatment parameters used during blood treatment (e.g., calcium or citrate addition rate).
If the treatment is suspended for any reason (e.g., necessary intervention on a patient who has not undergone blood treatment, detection of any condition, necessity of third party intervention, etc.), the control means deactivates (i.e., turns off) the citrate adding means. At the same time, the control means maintains the calcium adding activity (i.e. open) for a second period of time. This second time period corresponds to the time it takes for the system to run blood through the entire extracorporeal circuit for extracorporeal blood treatment once.
In some cases, the first time period (i.e., when only citrate addition is active) and the second time period (i.e., when only calcium addition is active) may overlap. In this case, the control means keeps the citrate adding means active during the first period of time while the citrate treated blood is filtered through the dialyzer. At the beginning of the second period of time, the control means deactivates the citrate adding means while activating the calcium adding means. In this case, the first period of time continues until the control means deactivates the citrate adding means. The second time period corresponds to the time the system is in use in processing. (the maximum value of the second period of time corresponds to the time it takes for the system to run the blood through the whole extracorporeal circuit for extracorporeal blood treatment once.) the volume of blood supplemented with calcium ions should be the same volume filtered by the system (since only said blood needs to be supplemented, with the calcium ions removed by the purging operation during the treatment).
In some cases, it is possible and permissible for the above situations to change from one another.
In an advantageous embodiment of the invention, the second time period and the first time period are set by the control means to be substantially equal to the time it takes for the system to run blood through the entire extracorporeal circuit for extracorporeal blood treatment once.
In a modification of the described embodiment, the control unit additionally uses information about the given flow rate of the blood and the time used in the treatment (i.e. active clearance) by the system for extracorporeal blood treatment to calculate the first and second time periods.
In an advantageous embodiment of the invention, the user determined calcium addition rate is constant during the blood treatment. Alternatively, the user-determined calcium addition rate is variable during the blood treatment.
In another advantageous embodiment of the invention, the control unit activates and/or deactivates the calcium adding means and/or the citrate adding means in order to maintain the calcium level in the blood (extracorporeal and in vivo blood) at the user determined calcium concentration.
Another aspect of the invention relates to a method of controlling a system for extracorporeal blood treatment to ensure adequate calcium supplementation after citrate anticoagulation, the method comprising the steps of:
feeding blood through the extracorporeal blood circuit, preferably at a predetermined flow rate (volume/second).
-initiating the addition of citrate to the blood volume,
-starting the blood treatment for a first period of time until the whole extracorporeal blood volume is treated,
-performing an addition of calcium to the blood volume after a first period of time has elapsed (starting a periodic filtration period),
maintaining citrate addition until the end of the blood treatment (end of the periodic treatment period), at which point citrate addition is stopped,
-maintaining calcium addition during blood treatment to stably maintain a user determined calcium addition rate,
after the end of the blood treatment (end of the periodic treatment period), the addition of calcium is continued until a second time period has elapsed after the end of the treatment, starting from the end of the blood treatment, which is required to add calcium to the treated extracorporeal blood volume in the system,
-stopping the addition of calcium,
-returning the extracorporeal blood to the patient.
In an advantageous embodiment of the method, the first and second time periods correspond to the time it takes for the system to run blood through the entire extracorporeal circuit for extracorporeal blood treatment once.
In a modification of the embodiment, the first and second time periods may be shorter than the period described above.
In addition, the time lengths of the first and second time periods may be calculated taking into account information about the current flow rate of blood through the system for extracorporeal blood treatment during the first and second time periods and the volume of the treated blood volume (filtered blood volume).
In an embodiment of this method, the length of the second time period is determined using feed forward control, using information about the length of the first time period.
The method according to the invention allows: during blood treatment, the citrate addition rate and the calcium addition rate to the blood volume are set to maintain the calcium level in the blood (extracorporeal and intracorporeal blood) at the user-determined calcium concentration. The user-determined calcium addition rate of the calcium addition member may be constant or variable during the course of the blood treatment, the method according to the invention providing increased flexibility for the physician performing the blood treatment.
Drawings
Other features and advantages of the present invention will become more apparent from the following description with reference to fig. 1 and 2, respectively.
Fig. 1 shows a diagram of a system for extracorporeal blood treatment according to the present invention.
Fig. 2 shows a process diagram of a method for controlling a system for extracorporeal blood treatment, which method ensures sufficient calcium supplementation for citrate anticoagulation.
Detailed Description
Fig. 1 shows a system 1 for extracorporeal blood treatment, for example a hemodialysis machine, comprising a hemofilter 2; a blood pump 3 for pumping blood through the hemofilter 2; a citrate pump 4 configured to add citrate to the blood and arranged upstream of the blood filter 2 in the direction of blood flow through the blood filter 2; a calcium pump 5 configured to add a calcium solution to the blood, and arranged downstream of the hemofilter 2 in the direction of the blood flow through the hemofilter 2; and an Electronic Control Unit (ECU)6 configured to activate or deactivate (i.e., turn on and off) the citrate pump 4 and/or the calcium pump 5. Further, the hemodialysis machine includes: an inlet 11 allowing the dialysis fluid to flow into the hemofilter 2; and an outlet 12 allowing the dialysis fluid to flow out of the hemofilter 2. The dialysis fluid flows through the blood filter 2 in a direction opposite to the direction of the blood flow through the blood filter 2. Just at the beginning of the blood treatment, the ECU6 switches the citrate pump 4 on. The first period of time continues until the total external blood volume of the system has run through the circuit of the hemodialysis machine once, the citrate pump 4 is kept on, and the blood is filtered through the hemofilter 2. When the total external blood volume has been treated, the ECU6 switches on the calcium pump 5 at a user-defined flow rate while continuing to operate the citrate pump 4. This state is maintained until processing is stopped for any reason. The rate of addition of calcium and/or citrate can be varied by the user/physician during the course of blood treatment. If the citrate treatment is stopped and the citrate pump 4 is inactive, but the blood pump 3 is still running, the ECU6 maintains the calcium pump 5 in an active state/on. The ECU6 may maintain the calcium pump 5 in an active state for a second period of time corresponding to the time it takes for the extracorporeal total blood volume of the system to run through the circuit of the hemodialysis machine 1 once. In this case, the process may be stopped. Alternatively, if the process is to be continued and the citrate pump 4 is activated again by the ECU6, the ECU6 deactivates the calcium pump 5. Subsequently, when the total external blood volume has been filtered, the ECU6 restarts the calcium pump 5. The ECU6 does not directly exert any control over the calcium concentration in the blood during the entire course of blood treatment. Instead, the user/physician defines the calcium and citrate addition rates. The ECU6 defines only the periods of time during which the citrate pump 4 and the calcium pump 5 are active/inactive.
Fig. 2 shows a process diagram of a method of controlling a system for extracorporeal blood treatment to ensure adequate calcium supplementation after citrate anticoagulation by adjusting the timing sequence (which may include overlap) of citrate and calcium addition. Two related diagrams are shown. In both cases, time is shown on the x-axis. The y-axis shows the patient volume on the upper diagram and the extracorporeal volume on the lower diagram. When the patient is newly connected to the system for extracorporeal blood treatment, the citrate treated and filtered blood volumes in the disposable set are zero, while the citrate, calcium and waste volumes in the patient's blood are all at their original levels. First, citrate addition is initiated, so that both the blood volume of the citrate treatment and the patient's citrate volume begin to increase in the disposable set. After the treatment has started, the treated blood volume starts to increase in the disposable set, while the citrate treated blood volume increases further. At the same time, the patient's citrate volume stops increasing because citrate is no longer pumped further back to the patient. During therapy, no more citrate burden occurs and the amount administered to the patient is broken down by metabolic processes. The citrate treated blood volume and the filtered blood volume continue to increase until they reach the amount of total extracorporeal blood volume, respectively. Until the filtered blood volume does not reach the total extracorporeal blood volume, calcium is removed from the blood without replacement, and the patient's calcium volume is reduced. After the filtered blood volume reaches the amount of the extracorporeal blood volume, the addition of calcium is started. Thus, the filtered calcium is replaced and the calcium volume of the patient remains unchanged. At the same time, the volume of waste in the patient's blood decreases until the end of the treatment. At the end of the treatment, citrate addition is stopped and thereafter the citrate treated blood volume and the filtered blood volume will decrease in the disposable set while calcium addition remains active. Thus, the calcium volume of the patient will increase and the volume of waste products in the blood of the patient remains unchanged. Since the time when calcium extraction was performed without replacement (t1) and when calcium replacement was performed without extraction (t2) were considered to be equal, the calcium volume of the patient was equal to the original volume. In summary, a system for extracorporeal blood treatment is provided, having:
a blood filtration device;
a member for pumping blood through a blood filtration device; a citrate adding member arranged upstream of the blood filtration device in the direction of blood flow, the citrate adding member being configured to add citrate to the blood; a calcium addition member disposed downstream of the blood filtration device in a direction of blood flow, the calcium addition member configured to add a calcium solution to blood; and a control means configured to activate or deactivate the citrate adding means and/or the calcium adding means, wherein the control means activates the citrate adding means at the start of the blood treatment and filters the blood with the activated citrate adding means for a first period of time and continues to operate the citrate adding means until the end of the blood treatment; at this point in time, the citrate adding means is deactivated, the control means activates the calcium adding means after a first period of time has elapsed, the control means continues to operate the calcium adding means in an active state during the blood treatment to stably maintain the user determined rate of calcium addition when the total external blood volume in the system has been filtered and citrate treated, and after the blood treatment is ended, the calcium adding means in an active state continues to operate until a second period of time has elapsed after the treatment is ended. Furthermore, the invention also includes a method of controlling such a system for extracorporeal blood treatment to ensure sufficient calcium supplementation after citrate anticoagulation.
Claims (6)
1. A system (1) for extracorporeal blood treatment, the system having:
a blood filtration device (2); a member (3) for pumping blood through the blood filtration device (2); a citrate adding member (4), the citrate adding member (4) being arranged upstream of the blood filtration device (2) in the direction of blood flow, the citrate adding member (4) being configured to add citrate to the blood; a calcium addition member (5), the calcium addition member (5) being arranged downstream of the blood filtration device (2) in the direction of blood flow, the calcium addition member being configured to add calcium to the blood; and a control unit (6), the control unit (6) being configured to activate or deactivate the citrate adding means (4) and/or the calcium adding means (5); wherein the control unit (6) is adapted to:
-activating the citrate adding means (4) at the beginning of a blood treatment process;
-determining the lapse of a first time period (t1) after initiating the actual blood treatment;
-after the first period of time has elapsed, activating the calcium adding means (5) when the total external blood volume in the system has been filtered and citrate treated;
characterized in that said control unit (6) is further adapted to:
-continuing to operate the citrate adding means (4) until the end of the actual blood treatment, at which point the citrate adding means (4) is deactivated;
-continuously operating the calcium adding member (5) in an activated state during the actual blood treatment to stably maintain the user determined calcium adding rate;
-continuing to operate the calcium adding member (5) in the activated state after the end of the actual blood treatment until a second time period (t2) has elapsed after the end of the actual blood treatment; and
-setting the length of the second time period (t2) using a time-series feedforward control, using information about the length of the first time period (t1), wherein the second time period (t2) and the first time period (t1) are set by the control unit (6) to be substantially equal to the time it takes for the total external blood volume of the system to run through the entire circuit of the system (1) for an extracorporeal blood treatment once.
2. The system (1) according to claim 1, characterized in that: the control unit (6) calculates the first and second time periods (t1, t2) using information about the current flow rate of blood through the system (1) for extracorporeal blood treatment.
3. The system (1) according to any one of the preceding claims, wherein: the user determined calcium addition rate is constant during the blood treatment.
4. The system (1) according to claim 1 or 2, characterized in that: the user-determined calcium addition rate is variable during the blood treatment.
5. The system (1) according to claim 1 or 2, characterized in that: the control unit (6) activates and/or deactivates the calcium adding means (5) and/or the citrate adding means (4) to maintain the calcium level in the blood at a user determined calcium concentration both in vitro and in vivo.
6. The system (1) according to claim 5, characterized in that: during the blood treatment, the user-determined calcium concentration in the blood may be adjusted by a user during the blood treatment.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14191205.5A EP3015124B1 (en) | 2014-10-31 | 2014-10-31 | System for flexible citrate anticoagulation during extracorporeal blood treatment using feed-forward control |
| EP14191205.5 | 2014-10-31 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN105561416A CN105561416A (en) | 2016-05-11 |
| CN105561416B true CN105561416B (en) | 2020-05-15 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510646690.2A Active CN105561416B (en) | 2014-10-31 | 2015-10-08 | System for extracorporeal blood treatment |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US10953146B2 (en) |
| EP (1) | EP3015124B1 (en) |
| JP (1) | JP6579896B2 (en) |
| CN (1) | CN105561416B (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018087327A1 (en) * | 2016-11-11 | 2018-05-17 | Biosurgical S.L | Filtration apparatus |
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| CN105561416A (en) | 2016-05-11 |
| US20160121035A1 (en) | 2016-05-05 |
| EP3015124B1 (en) | 2017-08-16 |
| JP2016087438A (en) | 2016-05-23 |
| JP6579896B2 (en) | 2019-09-25 |
| EP3015124A1 (en) | 2016-05-04 |
| US10953146B2 (en) | 2021-03-23 |
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